How Do You Measure Quality Culture in FDA-Regulated Industry?

Jack Garvey |

Quality culture can be extremely difficult to measure quantitatively…especially for companies regulated by the FDA. In this video, CEO Jack Garvey explains how organizations can begin to quantify their “quality culture” in an effort to benchmark and improve performance.

People know, kind-of, qualitatively, what a company’s culture is, but that, thumb-in-the-air, “Yeah, I think they’ve got a bad culture,” does not work for executive stakeholders that are looking to make investments to improve their culture, or believe that there may be a problem where something doesn’t exist. In the journey of developing our model, we’ve figured out, using a great deal of science that has been established, how to essentially create semi-quantitative measures of a qualitative concept.

We do that through decomposition of the concept of culture in a qualitative sense, into constituent elements…and measuring, at a lower level, those constituent elements, and then being able to roll that up into a higher level, and really getting out to a single numerical score.  So, it’s really a decomposition process of characteristics of something that’s qualitative, getting down to lower levels where you could actually assign quantitative measures, and then rolling that back up again.  It’s something that we apply, as I said, not only to culture. We’ve applied it to risk, and there are certainly other concepts that sort of process is available, and it’s very valid. It may not be precise, but it is highly directional, and very indicative of where we are in the spectrum with respect risk, with respect to culture, or other types of what I’ll call, “subjective qualitative concepts.”

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